Guidant To Push Drug Eluting Stent Program In 2005
This article was originally published in The Pink Sheet Daily
Cordis/Guidant drug-eluting stent technology integration slows as Cordis addresses FDA warning letter citing regulatory, quality issues. Champion DES fracture issue solved, Guidant says; redesigned Champion premarket filings to occur in first quarter next year.
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CEO Hunter says Angiotech will follow specialty pharma model of risk, lifecycle management to achieve lasting success. The company also has started a venture capital unit and plans to vertically integrate its business.
The company will begin enrollment of a 1,700-patient U.S. pivotal trial in coming weeks. Conor is touting the paclitaxel-eluting stent as unique because it incorporates hundreds of small holes that act as reservoirs, which can be loaded with a drug-polymer combination for more controlled release over time.
Boston Scientific's suit against Conor Medsystems over paclitaxel will draw from a $75 mil. legal reserve established by the Taxus manufacturer in 2004. Angiotech is joining Boston Scientific in suing Conor over the CoStar drug-eluting stent, seeking to halt use of clinical trial data, potential sales.